White Papers

Informational resources created to give industry professionals a more detailed look at specific areas of the clinical research industry.

To download a white paper, click on the appropriate button and follow the registration instructions on that page. Once your information is received, we will send you an email with a link to download the PDF.

Right to Try laws have passed in 32 states. The laws grant patients access to investigational drugs if they have a terminal illness, they’ve considered other options and their doctor will give them a prescription for it. Biopharmaceutical companies can choose to sell the drugs to patients or they can offer the drug for free. The laws purport to make the process faster and easier on patients than the FDA expanded access program; however, the Pharmaceutical Research and Manufacturers of America (PhRMA) would rather see patients gain access to investigational drugs under the oversight of the FDA and IRBs.

The concept of gamification is helping to solve complex scientific problems while offering patients incentives to comply with their medical regimens through mobile gaming systems that reward adherence, help diagnose illnesses, explain clinical trials and recruit patients. Researchers hope that these kinds of games can train the brain to improve being mindful, aware and alert. Developers would like to make a positive and rewarding experience through good thought patterns and sharp cognitive functions.

The growth of commercially available wearable devices capable of gathering health information doesn’t seem to be slowing any time soon. These devices hold promise for collecting, transmitting and integrating objective experiential data in real time and in aiding the analysis of a much higher volume of data from a significantly larger number of patients. The prospect of a potentially large market for new devices that can shorten clinical trial cycle times and engage larger numbers of patients is compelling.

CenterWatch analysis of the global clinical trial grants market, a critical measure of the overall health of the enterprise, revealed a mixed message about the volume of clinical activity. The white paper delves into the reasons behind why the volume of clinical activity is rising while growth in grant spending has slowed significantly:

Industry-sponsored clinical trial activity has increased compared to a decade ago, yet growth in grant spending to investigative sites from both
the government and industry has continued to slow significantly.

Total spending on global clinical trial grants to sites reached $13.5 billion in 2014, growing about 2% a year since 2008.

Growth in government grant spending, in particular, declined -1.8% each year since 2008, while growth in industry spending during the past six years slowed to one-third of its previous level.

The deceleration of growth in grant spending raises concerns for sites, which already have seen profit margins erode over the past six years and feel pressure from sponsors
and CROs to perform at higher levels for the same grant dollars.

Growth in grant spending also has been affected by the increasing complexity of clinical trial protocols.

Major CROs now consider patient recruitment services, once used primarily to rescue under-enrolling studies, as a core activity in study planning. Providing strategies for patient recruitment has become critical to staying competitive in the marketplace.

The white paper delves into exactly how, and to what extent, large CROs and stand-alone patient recruitment companies are jockeying for exposure:

Large CROs have moved into the space as the entire industry redefines patient recruitment practice with new technologies and strategies.

Electronic medical records and other patient data sources have allowed more effective and cost-efficient targeting of patients.

The internet and mobile devices have opened more channels for raising awareness about clinical trials and communicating with patients.

Stand-alone patient recruitment companies are stepping up tactics and developing innovative ways to reach potential patients in order to compete in the changing landscape.

The landscape will continue to evolve because patient recruitment remains one of the biggest challenges in clinical research.

Private equity (PE), which has been very active in the CRO space over the past five years, is reshaping the CRO landscape—giving the industry financial stability it might not otherwise have and providing the capital for CROs to expand, both organically and inorganically, to offer a broader range of services and greater efficiency to support R&D operations. The white paper delves into exactly how, and to what extent, PE is driving CRO growth.

PE has changed the look of the industry over the past 10 years.

It has added a level of credibility to the space by being willing to buy an asset like a CRO.

While there is wide agreement that the regulatory compliance burden for sites is high, few initiatives have been launched in the industry and little to no data exists to quantify this regulatory compliance burden on sites. A new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.

The potential benefits of cloud computing in clinical trials—lower R&D costs, ease of use, rapid scalability, flexibility, availability--are beginning to outweigh the complexities and challenges of finding the right vendors. CenterWatch takes a look at how this new trend is shaping the industry including a case study of a company's recent transition.

This new report gives current RBM users the ability to compare the RBM methods they currently employ to those utilized by a large sample of biopharmaceutical, CRO and academic research organizations. It also gives new RBM users information that will allow them to accelerate and focus their implementation. The report includes over 40 figures, tables and graphs covering a wide range of areas.

For physician investigators, CRCs and CRAs, there are certification programs which are highly regarded, but there are no formal regulations which define the educational or experiential requirements to conduct clinical research. This paper will discuss the newly formed Joint Task Force for Clinical Trial Competency (JTF) and its work towards creating a single, high-level set of standards which could serve as a framework for defining professional competency throughout the clinical research enterprise.

Originally hired by sponsors to perform outreach with payers and providers
while their drugs were awaiting FDA approval, medical science liaisons have seen their role evolve dramatically over time into more of a global pharmacological
resource who can present data in a fair and clear way for the improvement and benefit of patients and the overall public health sector.

High turnover and an influx of novice investigators have been the key drivers plaguing the site workforce recently. CenterWatch analyzes the reasons for the shift and the affects it's having on the industry.

SMOs have faded steadily in the U.S. since this trend piqued in the late 90s, yet they continue to flourish worldwide. CenterWatch explores whether or not there's still a U.S. market for these companies.